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Official Title: a Phase 1 Open Label, Dose-Escalation Clinical Trial To Official Title: A Phase 1 Open Label, Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Trivalent Virus-Like Particle (VLP) Encephalitis Vaccine, VRC-WEVVLP073-00-VP, in Healthy Adults ClinicalTrials.gov Identifier: NCT03879603 Document Type: • Redacted Study Protocol, including Letters of Amendment (Statistical Analysis Considerations located in Section 6 of the Protocol) • Redacted IRB-approved Version 2.0 Informed Consent (dated March 12, 2019) Document/Date: • Protocol Version 1.0: January 9, 2019 • Protocol Version 1.0, Letter of Amendment #1: March 12, 2019 • Protocol Version 1.0, Letter of Amendment #2: April 23, 2019 • Protocol Version 1.0, Letter of Amendment #3: October 24, 2019 • Version 2.0 IRB-approved Informed Consent (dated March 12, 2019 with March 18, 2019 IRB- approval) Version 1.0 January 9, 2019 VACCINE RESEARCH CENTER Protocol VRC 313 A PHASE 1 OPEN LABEL, DOSE-ESCALATION CLINICAL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A TRIVALENT VIRUS-LIKE PARTICLE (VLP) ENCEPHALITIS VACCINE, VRC-WEVVLP073-00-VP, IN HEALTHY ADULTS Vaccine Provided by National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) Bethesda, Maryland Clinical Trial Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) Bethesda, Maryland BB-IND 11738 – held by VRC, NIAID, NIH Clinical Trial Management Leidos Biomedical Research, Inc. Frederick, Maryland, USA Protocol Chairs Julie Ledgerwood, D.O. Cristina A. Carter, M.D. VRC, NIAID, NIH Bethesda, MD 20892 Clinical Research Site Principal Investigator: Srilatha Edupuganti, MD; MPH IRB Initial Review Date: February 20, 2019 Confidentiality Statement This document is confidential and is to be distributed for review only to investigators, potential investigators, consultants, study staff, and applicable independent ethics committees or institutional review boards. The contents of this document shall not be disclosed to others without written authorization from NIAID (or others, as applicable), unless it is necessary to obtain informed consent from potential study subjects. PRODUCT: VRC-WEVVLP073-00-VP PROTOCOL VRC 313, VERSION 1.0 PROTOCOL DATE: JANUARY 9, 2019 Statement of Compliance The trial will be conducted in compliance with the protocol, the applicable regulatory requirements including but not limited to the United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR 46, 21 CFR including parts 50 and 56 concerning informed consent and Institutional Review Board (IRB)/Ethics Committee (EC) regulations, and 21 CFR 312 concerning Investigational New Drug (IND) application), International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidance, and the NIAID Clinical Terms of Contract Award. Each site will hold a current Federal Wide Assurance (FWA) issued by the Office for Human Research Protections for federally funded research. Completion of Protection of Human Subjects Training will be required for all study personnel in accordance with National Institutes of Health (NIH) policy. Page 2 of 66 PRODUCT: VRC-WEVVLP073-00-VP PROTOCOL VRC 313, VERSION 1.0 PROTOCOL DATE: JANUARY 9, 2019 PRINCIPAL INVESTIGATOR PROTOCOL SIGNATURE PAGE VRC 313: A Phase 1 Open Label, Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Trivalent Virus-Like Particle (VLP) Encephalitis Vaccine, VRC- WEVVLP073-00-VP, in Healthy Adults. Sponsored by: Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) I, the Principal Investigator for the indicated VRC 313 Study Site, agree to conduct this study in full accordance with the provisions of this protocol and protocol amendments. I will comply with all requirements regarding the obligations of investigators as outlined in the Statement of Investigator (Form FDA 1572), which I have also signed. I agree to maintain all study documentation pertaining to the conduct of this study, including, but not limited to, case report forms, source documents, consent forms, laboratory test results, and medication inventory records, for at least 2 years following submission of a United States Biologics License Application. If no marketing application is filed, or if the application is not approved, the records will be retained for two years after the investigation is discontinued and the US Food and Drug Administration is notified. No study records will be destroyed without prior authorization from VRC/NIAID. Publication of the results of this study will be governed by the VRC/NIAID policies. Any presentation, abstract, or manuscript will be made available by the investigators to VRC Leadership and to NIAID for review prior to submission. I have read and understand the information in this protocol and the Investigator’s Brochure and will ensure that all associates, colleagues, and employees assisting in the conduct of the study are informed about the obligations incurred by their contribution to the study. __________________________________ ________________________ Name/Title of Principal Investigator Study Site Name/Identifier __________________________________ ________________________ Signature of Principal Investigator Date Page 3 of 66 PRODUCT: VRC-WEVVLP073-00-VP PROTOCOL VRC 313, VERSION 1.0 PROTOCOL DATE: JANUARY 9, 2019 TABLE OF CONTENTS TABLE OF ABBREVIATIONS .....................................................................................................8 PRÉCIS ……………………………………………………………….……………………….9 1 INTRODUCTION ......................................................................................................10 1.1 Etiology, Epidemiology, and Disease Course ............................................................10 1.2 Rationale for the Development of the WEVEE Vaccine ............................................10 1.3 Rationale for the Use of Aluminum–Based Adjuvant ................................................11 1.3.1 Animal Experience with WEVEE VLP and Aluminum-based Adjuvants .................11 1.4 Previous Human Experience .......................................................................................12 1.4.1 VRC-CHKVLP-59-00-VP (CHIK VLP) Vaccine and Other VLP Vaccines ............12 1.4.2 Human Experience with Other Alphavirus Vaccines .................................................13 1.4.3 Previous Human Experience with Aluminum-based Adjuvants ................................13 1.5 Rationale for Study Design .........................................................................................14 1.6 Assessment of Immunogenicity ..................................................................................14 2 STUDY PRODUCTS .................................................................................................14 2.1 VRC-WEVVLP073-00-VP, Study Product ................................................................14 2.2 VRC-GENMIX083-AL-VP, Adjuvant .......................................................................14 2.3 VRC-PBSPLA043-00-VP, Diluent ............................................................................14 2.4 Preclinical Studies of VRC-WEVVLP073-00-VP .....................................................15 3 STUDY OBJECTIVES ..............................................................................................15 3.1 Primary Objectives .....................................................................................................15 3.2 Secondary Objectives .................................................................................................15 3.3 Exploratory Objectives ...............................................................................................15 4 STUDY DESIGN AND CLINICAL PROCEDURES ...............................................15 4.1 Study Population .........................................................................................................16 4.1.1 Inclusion Criteria ........................................................................................................16 4.1.2 Exclusion Criteria .......................................................................................................17 4.2 Clinical Procedures And Evaluations .........................................................................18 4.2.1 Pre-screening ..............................................................................................................18 4.2.2 Screening ....................................................................................................................18 4.2.3 Enrollment ..................................................................................................................19 4.2.4 Randomization ............................................................................................................19 4.2.5 Study Schedule ...........................................................................................................20 Page 4 of 66 PRODUCT: VRC-WEVVLP073-00-VP PROTOCOL VRC 313, VERSION 1.0 PROTOCOL DATE: JANUARY 9, 2019 4.2.6 Product Administration ...............................................................................................21 4.2.7 Safety Evaluations and Follow-up after Product Administration ...............................22 4.2.8 Blood Sample Collection ............................................................................................22
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